to Index Page
Note from FAN:
This Final Rule contains a separate
document that is EPA's response to FAN's comments
on BASF's original petition- see
in EPA Docket, Number: OPP-2004-0362-0002)
Aug 11, 2003: FAN's comments on BASF's petition
for this tolerance at
Sept 17, 2003: BASF's response to FAN's
The nature of the toxic effects caused by chlorfenapyr are discussed
in a September 26, 2003, Final Rule at http://www.fluorideaction.org/pesticides/chlorfenapyr.fr.sept26.2003.htm
See BASF's petition (July 16, 2003) for this Tolerance at
Chlorfenapyr; Pesticide Tolerance [Federal Register: January
26, 2005 (Volume 70, Number 16)]
[Rules and Regulations]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Chlorfenapyr; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes a tolerance for residues of
pyrrole-3-carbonitrile in or on all foods except fruiting vegetables.
BASF Corporation requested this tolerance under the Federal Food,
and Cosmetic Act (FFDCA), as amended by the Food Quality Protection
of 1996 (FQPA).
DATES: This regulation is effective January 26, 2005. Objections
requests for hearings must be received on or before March 28, 2005.
ADDRESSES: To submit a written objection or hearing request, follow
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under
identification (ID) number OPP-2004-0362. All documents in
docket are listed in the EDOCKET index at http://www.epa.gov/edocket
Although listed in the index, some information is not publicly
available, i.e., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically in EDOCKET, or in hard copy at the
Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall #2, 1801 S. Bell St., Arlington, VA. This docket
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The docket telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Ann Sibold, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection
1200 Pennsylvania Ave., NW.,Washington, D.C. 20460-0001; telephone
number: 703 305-6502; e-mail address: firstname.lastname@example.org .
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
• Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery, and
floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by
action. Other types of entities not listed in this unit could also
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
B. How Can I Access Electronic Copies of this Document and Other
In addition to using EDOCKET ( http://www.epa.gov/edocket/ ), you
access this Federal Register document electronically through the
Internet under the ``Federal Register'' listings at http://www.epa.gov/
fedrgstr/ . A frequently updated electronic version of 40 CFR part
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/
To access the OPPTS Harmonized Guidelines referenced in this
document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.
II. Background and Statutory Findings
In the Federal
Register of July16, 2003 (68 FR 42022) (FRL-7312-7),
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 3F6560)
by BASF Corporation, 26 Davis Drive, Research Triangle Park, North
Carolina 27709. The petition requested that 40 CFR 180.513 be amended
by establishing a tolerance for residues of the insecticide 4-bromo-2-
carbonitrile, chlorfenapyr, in or on all foods
at 0.01 parts per
million (ppm). That notice included a summary of the petition
by BASF Corporation, the registrant. Three public comments (OPP-2003-
0205-0001 (Green Party, MI), OPP-2003-0205-0002 (Fluoride Action
OPP-2003-0205-0003 (BASF Corporation)) were received in response
registrant's petition. The substantive public
corresponding Agency responses are addressed in a separate
available in the docket for this action under Docket identification
(ID) number OPP-2004-0362.
The Green Party, MI took exception with the use of a tolerance
provide a `` safe'' level of pesticide residues in food. The Agency
acknowledges this comment but notes that the Agency is authorized
section 408(b)(A)(i) of the Federal Food, Drug, and Cosmetic Act
establish tolerances. The Fluoride Action
Network (FAN) provided a
number of comments on the Agency's safety determination for
chlorfenapyr including raising concerns about: (1) its role in ``Mad
Cow Disease'' (transmissible spongiform encephalopathies), (2)
aggregate exposure to chlorfenapyr and other fluorine and bromine
containing pesticides and inerts, (3) aggregate exposure to
chlorfenapyr and other neurotoxicants, (4) its role in
neurodegenerative diseases and disease processes, (5) the status
conditionally required developmental neurotoxicity study, and (6)
public access to risk assessments and other supporting documentation.
BASF, the chlorfenapyr registrant, provided a detailed
response to the
issues raised by FAN.
The substantive public comments and corresponding Agency responses
are addressed in a separate document available in the docket for
action under Docket identification (ID) number OPP-2004-0362. The
Agency considered all of the substantive comments and saw no basis
support the claims that were made in the public comments. Again,
Agency's complete reasoning is discussed in the comment response
document. As to FAN's comments regarding access to Agency documents
chlorfenapyr, EPA would note that there are extensive documents
chlorfenapyr on EPA's website. However, the Agency agrees with the
comment that generally more access to information supporting this
other decisions is desirable, and in fact, the Registration Division,
Office of Pesticide Programs is currently reviewing its procedures
docketing to address this concern.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue
. . .``
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion
regulatory requirements of section 408 of FFDCA and a complete
description of the risk assessment process, see the final rule on
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997)
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed
available scientific data and other relevant information in support
this action. EPA has sufficient data to assess the hazards of and
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for a tolerance for residues of chlorfenapyr
foods except fruiting vegetables at 0.01 ppm. EPA's assessment of
exposures and risks associated with establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants
children. The nature of the toxic effects
caused by chlorfenapyr as
well as the no-observed-adverse-effect-level (NOAEL) and the lowest-
observed-adverse-effect-level (LOAEL) from the toxicity studies
reviewed are discussed in the Federal
Register of September 26, 2003
(Vol. 68 No. 187 FR 55519-55527) (FRL-7320-8).
B. Toxicological Endpoints
The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological level of concern
(LOC). However, the lowest dose at which adverse effects of concern
identified (the LOAEL) is sometimes used for risk assessment if
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population
as other unknowns. An UF of 100 is routinely used, 10X to account
interspecies differences and 10X for intraspecies differences.
Three other types of safety or uncertainty factors may be used:
``Traditional uncertainty factors;'' the ``special FQPA safety
factor;'' and the ``default FQPA safety factor.'' By the term
``traditional uncertainty factor,'' EPA is referring to those
additional uncertainty factors used prior to FQPA passage to account
for database deficiencies. These traditional uncertainty factors
been incorporated by the FQPA into the additional safety factor
protection of infants and children. The term ``special FQPA safety
factor'' refers to those safety factors that are deemed necessary
the protection of infants and children primarily as a result of
FQPA. The ``default FQPA safety factor'' is the additional 10X safety
factor that is mandated by the statute unless it is decided that
are reliable data to choose a different additional factor (potentially
a traditional uncertainty factor or a special FQPA safety factor).
For dietary risk assessment (other than cancer) the Agency uses
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by an UF
100 to account for interspecies and intraspecies differences and
traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF).
Where a special FQPA safety factor or the default FQPA safety factor
used, this additional factor is applied to the RfD by dividing the
by such additional factor. The acute or chronic Population Adjusted
Dose (aPAD or cPAD) is a modification of the RfD to accommodate
type of safety factor.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL
exposures (margin of
exposure (MOE) = NOAEL/exposure) is calculated and compared to
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk). An example of how such a probability risk is expressed
would be to describe the risk as one in one hundred thousand (1
10-5), one in a million (1 X
10-6), or one in ten million (1 X
10-7). Under certain specific circumstances, MOE
calculations will be used for the carcinogenic risk assessment.
nonlinear approach, a ``point of departure'' is identified below
carcinogenic effects are not expected. The point of departure is
typically a NOAEL based on an endpoint related to cancer effects
it may be a different value derived from the dose response curve.
estimate risk, a ratio of the point of departure to exposure
(MOEcancer= point of departure/exposures) is calculated.
A summary of the toxicological endpoints for
chlorfenapyr used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal
Register of September 26, 2003 (Vol. 68 No.
187 FR 55519-55527) (FRL-7320-8).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. The tolerance
established in 40 CFR 180.513 is further amended to set tolerances
residues of chlorfenapyr in or on all foods except fruiting vegetables
at 0.01 ppm. Risk assessments were conducted by EPA to assess dietary
exposures from chlorfenapyr in food as follows:
i. Acute exposure. Acute dietary risk assessments are performed
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a one-day
or single exposure.
In conducting the acute dietary risk assessment EPA used the
Dietary Exposure Evaluation Model software with the Food Commodity
Intake Database (DEEM-FCIDTMVersion 2.03), which
incorporates food consumption data as reported by respondents in
USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake
Individuals (CSFII) and accumulated exposure to the chemical for
food item. The 1994-96, and 1998 data are based on the reported
consumption of more than 20,000 individuals over two non-consecutive
survey days. Foods ``as consumed'' (e.g., apple pie) are linked
defined food commodities (e.g., apples, peeled fruit - cooked; fresh
baked; or wheat flour - cooked; fresh or baked) using publicly
available recipe translation files developed jointly by USDA/
Argricultural Research Service (ARS) and EPA. Consumption data are
retained as individual consumption events for acute exposure
assessment. The following assumptions were made for the acute exposure
assessments: Unrefined tier 1 acute dietary exposure assessments
tolerance-level residues and assuming 100% crop treated (CT) for
registered and proposed commodities, and default DEEMTM
Version 7.76 processing factors for all commodities were conducted.
acute dietary exposure estimates are below EPA's level of concern
(<100% aPAD) at the 95th exposure percentile for females 13-
49 years old (< 15% aPAD), and the general U.S. population (<
6% of the
aPAD), and all other population subgroups. The
most highly exposed
population subgroup (other than females 13-49 years old) is children
2 years old, at < 9% of the aPAD.
ii. Chronic exposure. In conducting the chronic dietary risk
assessment EPA used the DEEM-FCIDTM, which incorporates food
consumption data as reported by respondents in the USDA 1994-1996
1998 Nationwide Continuing Surveys of Food Intake by Individuals
(CSFII), and accumulated exposure to the chemical for each food
The 1994-96 and 1998 data are based on the reported consumption
than 20,000 individuals over two non-consecutive survey days. Foods
``as consumed'' (e.g., apple pie) are linked to EPA-defined food
commodities (e.g., apples, peeled fruit - cooked; fresh or baked;
wheat flour - cooked; fresh or baked) using publicly available recipe
translation files developed jointly by USDA/ARS and EPA. Consumption
data are averaged for the entire U.S. population and within population
subgroups for chronic exposure assessment. The following assumptions
were made for the chronic exposure assessments: unrefined, Tier
chronic dietary exposure using tolerance-level residues, assuming
CT for all registered and proposed commodities. The Agency concluded
that the chronic dietary exposure estimates are below HED's level
concern (< 100% cPAD for the general U.S. population (< 23%
of the cPAD)
and all population subgroups. The most highly
subgroup is children 1-2 years old, at < 45% of the cPAD.
2. Dietary exposure from drinking water. There is no concern for
exposure to residues of chlorfenapyr in drinking water based on
approved, pending and proposed directions for use and chlorfenapyr's
physical and chemical properties. Approved
uses in the United States
include applications to ornamental plants inside greenhouses, to
narrow band of soil adjacent to buildings and as a crack-and-crevice
and spot treatments inside non-food/feed structures. In food handling
areas chlorfenapyr is also applied as a crack-and-crevice and spot
treatment inside structures. Chlorfenapyr has extremely low
solubility (120 parts per billion at 25[deg] C) and is also immobile
soil and does not leach because it is strongly adsorbed to all common
3. From non-dietary exposure. The term ``residential exposure''
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
to chlorfenapyr is expected to be negligible based on assessments
by EPA for all currently approved uses: ornamentals grown in
greenhouses, as a termiticide, and for indoor applications for general
pest control. These assessments were based on the physicochemical
characteristics of the compound, the intended use patterns, and
available information concerning its environmental fate. The vapor
pressure of chlorfenapyr is less than 1 x 10-7 mm of mercury
(Hg). Therefore, the potential for non-occupational exposure by
inhalation is insignificant. These assessments also apply to the
food/feed handling areas as a crack-crevice and spot treatment.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance,
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not
a common mechanism of toxicity finding as to chlorfenapyr and any
substances and chlorfenapyr does not appear to produce a toxic
metabolite produced by other substances. EPA has also evaluated
comments submitted that suggested there might be a common mechanism
between chlorfenapyr and other named pesticides that cause brain
effects. EPA concluded that the
evidence did not support a finding of common mechanism for chlorfenapyr
and the named pesticides. For the purposes of this tolerance action,
therefore, EPA has not assumed that chlorfenapyr has a common mechanism
of toxicity with other substances. For information regarding EPA's
efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals,
the policy statements released by EPA's Office of Pesticide Programs
concerning common mechanism determinations and procedures for
cumulating effects from substances found to have a common mechanism
EPA's website at http://www.epa.gov/pesticides/cumulative/.
D. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold margin of safety for infants and children
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines based on reliable data that a different margin
safety will be safe for infants and children. Margins of safety
incorporated into EPA risk assessments either directly through use
MOE analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans.
applying this provision, EPA either retains the default value of
when reliable data do not support the choice of a different factor,
if reliable data are available, EPA uses a different additional
factor value based on the use of traditional uncertainty factors
special FQPA safety factors, as appropriate.
The Agency previously identified that a developmental
(DNT) study was required for chlorfenapyr, based on the presence
neuropathology (CNS lesions), and neurotoxic signs seen in adult
(males) and mice (both sexes). Considering the effects seen
doses at which those effects occurred, the Agency concluded that
safety factor is required until the data are received and evaluated.
2. Prenatal and postnatal sensitivity. There is no evidence
(qualitative or quantitative) for increased susceptibility following
utero exposure in the developmental toxicity studies in rats and
rabbits or prenatal/postnatal exposure in the 2-generation reproduction
study in rats. In both the rat and rabbit developmental toxicity
studies maternal toxicity included decreased body weight gain. No
developmental toxicity was noted in rats up to the highest dose
of 225 mg/kg/day. Developmental toxicity in rabbits (increased post
implantation loss) occurred at a higher dose than maternal toxicity.
the 2-generation reproduction study in rats, parental and offspring
toxicity included body weight decrements at similar doses. No
reproductive effects were noted up to the highest dose tested.
3. Conclusion. EPA evaluated the potential for increased
susceptibility of infants and children from exposure to chlorfenapyr.
EPA concluded that the toxicology data base
was incomplete for FQPA
purposes because a required DNT has not been submitted. The DNT
required due to the presence of neuropathology (central nervous
lesions) and neurotoxic signs seen in adult rats (males) and mice
sexes). Other than lacking the DNT study, EPA identified no residual
uncertainties for prenatal/postnatal toxicity. This decision is
on the following:
• There is no evidence (qualitative or quantitative) of
increased susceptibility of rat or rabbit fetuses to in utero exposure
in developmental toxicity studies. There is no evidence (qualitative
quantitative) of increased susceptibility of rat offspring in the
multi-generation reproduction toxicity study.
• There are no concerns or residual uncertainties for
prenatal and postnatal toxicity in the available developmental and
generation reproduction toxicity studies.
• The conservative residue assumptions used in the dietary
exposure risk assessments, and the completeness of the residue
E. Aggregate Risks and Determination of Safety
There are no existing or proposed uses of
chlorfenapyr which would
result in contamination of drinking water or residential exposures.
Therefore, an aggregate-exposure risk assessment was not performed.
IV. Other Considerations
A. Analytical Enforcement Methodology
Samples of composited meals from the subject study were analyzed
for residues of chlorfenapyr using American
Cyanamid GC/ECD (Gas
Chromatograph/Electron Capture Detector) Method M 2398. This
undergone a successful petition method validation (PMV). The reported
limit of quantitation (LOQ) is 0.01 ppm. The submitted concurrent
recovery data indicate that GC/ECD Method M 2398 is adequate for
determining residues of chlorfenapyr per se in/on composited meal
samples. The data requirement for multiresidue
methods has been
satisfied pending FDA review and acceptance of the multiresidue
An adequate enforcement methodology is available to enforce the
tolerance expression. The method may be requested
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905;
B. International Residue Limits
There are no established Codex, Canadian, or Mexican maximum
residue levels (MRLs) for chlorfenapyr on all foods except fruiting
vegetables at 0.01 ppm; therefore, harmonization of MRLs and U.S.
tolerances is not an issue at this time.
A tolerance has been previously established
fruiting. group 8, at 1.0 ppm. The
establishment of additional residue
level tolerances for chlorfenapyr on all food (as requested by the
petitioner) must therefore, exclude Vegetables, fruiting, group
registrant (BASF) was required to submit a revised Section F, excluding
Vegetables, fruiting, group 8 commodity from the petition. The
registrant (BASF) has met this condition. In addition, data are
required as a condition of registration. These were previously
discussed in Unit IV. C. of the final rule published in the
Register of September 26, 2003 (Vol. 68 No. 187 FR 55519-55527)
Therefore, the tolerance is established for residues of 4-bromo-2-
carbonitrile, chlorfenapyr, in or on all foods
fruiting group 8 at 0.01 ppm.
VI. Objections and Hearing Requests
Under section 408(g) of FFDCA, as amended by FQPA, any person may
file an objection to any aspect of this regulation and may also
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear
40 CFR part 178. Although the procedures in those regulations require
some modification to reflect the amendments made to FFDCA by FQPA,
will continue to use
those procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) of FFDCA provides
essentially the same process for persons to `` object'' to a regulation
for an exemption from the requirement of a tolerance issued by EPA
under new section 408(d) of FFDCA, as was provided in the old sections
408 and 409 of FFDCA. However, the period
for filing objections is now
60 days, rather than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2004-0362 in the subject line on the
first page of your submission. All requests must be in writing,
must be mailed or delivered to the Hearing Clerk on or before March
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on
hearing is requested, the requestor's contentions on such issues,
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of
information as CBI. Information so marked will not be disclosed
in accordance with procedures set forth in 40 CFR part 2. A copy
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to
Office of the Hearing Clerk in Suite 350, 1099 14th St.,
NW., Washington, DC 20005. The Office of the Hearing Clerk is open
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i)
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch,
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact
Tompkins by phone at (703) 305-5697, by e-mail at email@example.com,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: Information
Resources and Services Division (7502C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in ADDRESSES. Mail your
copies, identified by docket ID number OPP-2004-0362, to: Public
Information and Records Integrity Branch, Information Resources
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in ADDRESSES. You may also send an electronic copy
your request via e-mail to: firstname.lastname@example.org. Please use an ASCII
file format and avoid the use of special characters and any form
encryption. Copies of electronic objections and hearing requests
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner
by the requestor would be adequate to justify the action requested
VII. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office
Management and Budget (OMB) has exempted these types of actions
review under Executive Order 12866, entitled Regulatory Planning
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule
not contain any information collections subject to OMB approval
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of FFDCA, such as the tolerance in
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
seq.) do not apply. In addition, the Agency has determined that
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or
distribution of power and responsibilities among the various levels
government, as specified in
Executive Order 13132, entitled Federalism (64 FR 43255, August
1999). Executive Order 13132 requires EPA to develop an accountable
process to ensure ``meaningful and timely input by State and local
officials in the development of regulatory policies that have
federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or
distribution of power and responsibilities among the various levels
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. For these same reasons, the Agency
determined that this rule does not have any ``tribal implications''
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (59 FR 22951, November
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
order to include regulations that have ``substantial direct effects
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply
VIII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801et seq., as added by
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the
to each House of the Congress and to the Comptroller General of
United States. EPA will submit a report containing this rule and
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States
to publication of this final rule in theFederal Register. This final
rule is not a ``major rule '' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180 Environmental protection, Administrative
practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
Dated: December 24, 2004.
Acting Director, Registration Division, Office of Pesticide Programs.
• Therefore, 40 CFR chapter I is amended as follows:
• 1. The authority citation for part 180 continues to read
Authority: 21 U.S.C. 321(q), 346a and 371.
• 2. Section 180.513 is amended in
paragraph (a) by designating the text
following the paragraph heading General as paragraph (a)(1), and
adding paragraph (a)(2) to read as follows:
Sec. 180.513 Chlorfenapyr; tolerances for residues.
(a) General. (1) * * *
(2) A tolerance of
0.01 parts per million is established for
residues of chlorfenapyr in or on all food commodities (other than
those covered by a higher tolerance as a result of use on growing
crops) in food/feed handling areas where food/feed products are
prepared, held, processed, or served and in accordance with the
following prescribed conditions:
(i) Application shall be no
greater than a 0.5% active ingredient
solution for spot crack and crevice use in food/feed handling
establishments, where food and food products are held, processed,
prepared and/or served.
(ii) Application may only be undertaken when
the facility is not in
operation, and provided exposed food has been covered, or removed
the area being treated prior to application.
(iii) Food contact surfaces and equipment
should be throughly
washed with an effective cleaning compound, and rinsed with potable
water after each use of the product.
(iv) Contamination of food or food contact
surfaces shall be
avoided. Application excludes any direct application to any food,
packaging, or any food contact surfaces.
(v) To assure safe use, the label and labeling
shall conform to
that registered by the U.S. Environmental Protection Agency, and
shall be used in accordance with such label and labeling.
* * * * *
[FR Doc. 05-1439 Filed 1-25-05; 8:45 am]
BILLING CODE 6560-50-S